Novan Pharmaceutical’s SB204, an investigational once-daily, topical nitric oxide-based monotherapy for the treatment of acne vulgaris, showed superior efficacy to placebo and a high level of safety in a phase 3 pivotal trial focused on adolescent use.

The company presented pharmacokinetic, safety and efficacy data from the trial at the 13th World Congress of Pediatric Dermatology in Chicago, Illinois, last week. In the two replicate, multi-center, randomized, double-blinded, vehicle-controlled, parallel group trials, a total of 2,639 patients ages 9 and older with moderate to severe acne were enrolled across 110 sites in the United States. Overall results showed a statistically significant reduction in inflammatory, non-inflammatory and total lesion with SB204 4% compared to vehicle, while maintaining a favorable safety and tolerability profile.

In a post-hoc analysis of a subset of 905 adolescents ranging from ages 9 to under 17 years old treated topically with SB204 Gel 4% once-daily (n=439) or vehicle gel once-daily (n=466) for 12 weeks, the company found the following results:

The percent change from baseline in the number of non-inflammatory lesions was -33.4% for SB204 and -24.2% for vehicle (p=0.0013).

The percent change from baseline in the number of inflammatory lesions was -43.4% for SB204 and -36.4% for vehicle (p=0.0113).

The percent change from baseline in the number of total lesions was -37.4% for SB204 and -29.1% for vehicle (p<0.001).

No systemic exposure to markers for nitric oxide exposure under maximal use conditions was detected.

“It is encouraging to see a potential new therapy, with positive data, in development for the treatment of acne in adolescents,” said Diane Thiboutot, MD, of The Milton S. Hersey Medical Center in Hersey, Pennsylvania, and professor of dermatology at the Pennsylvania State University College of Medicine. “Acne is one of the most common skin conditions in children and teenagers, and its reach is far beyond the physical effects of the disease, extending to anxiety, depression and low self-esteem. A therapy that safely addresses the acne lesions without bothersome side effects is an unmet need for physicians, patients and parents.”